DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
Reported: January 1, 2025 Initiated: December 4, 2024 #D-0163-2025
Product Description
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
Reason for Recall
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
Details
- Recalling Firm
- PD-Rx Pharmaceuticals, Inc.
- Units Affected
- 70, 90-count bottles
- Distribution
- Distributed within US: FL, MS, WI
- Location
- Oklahoma City, OK
Frequently Asked Questions
What product was recalled? ▼
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90. Recalled by PD-Rx Pharmaceuticals, Inc.. Units affected: 70, 90-count bottles.
Why was this product recalled? ▼
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 1, 2025. Severity: Moderate. Recall number: D-0163-2025.
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